3 publishers · first seen Thu, 29 Oct 2026 05:05 UTC · updated Thu, 29 Oct 2026 07:52 UTC
The Indian Patent Office has rejected a patent application by the U.S.-based Global Alliance for TB Drug Development (TB Alliance) for the BPaL regimen, a combination of bedaquiline, pretomanid and linezolid used to treat drug-resistant tuberculosis. The decision, issued on October 27, 2026, under Section 15 of the Patents Act, 1970, upheld objections of lack of novelty, lack of inventive step, non-patentability and insufficient disclosure, following two pre-grant oppositions filed in 2020 by Eldred Tellis and Ganesh Acharya, and by the Delhi Network of Positive People (DNP+) with support from the Third World Network (TWN).
The BPaL regimen, recommended by the World Health Organisation, offers a six-month, all-oral treatment for eligible patients with multidrug- or rifampicin-resistant TB, and is part of India’s National TB Elimination Programme (NTEP), which also uses the BPaLM variant adding moxifloxacin. More than 15,000 patients have started BPaLM under the programme. The rejection may enable generic competition, potentially improving access and lowering costs, though actual availability depends on regulatory approvals and supply chain management. The patent application was numbered IN201817014361 and filed on April 16, 2018.
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